The Effect of Mental Toughness Interventions During Birth on the Pelvic Floor in the Postpartum Period

NCT07771647 | Completed

• 1 other identifier: TABED 1-25-1761
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled study aimed to determine the effect of mental toughness interventions initiated during the third trimester of pregnancy and applied during childbirth on pelvic floor-related distress in the postpartum period. The mental toughness interventions consisted of breathing exercises, relaxation exercises, focusing/concentration, and imagery. Pregnant women were randomly assigned to an intervention group or a control group. Participants in the intervention group were taught the mental toughness interventions during the third trimester and received follow-up training sessions at 32-34 and 36-38 weeks of gestation. During labor, the interventions were applied at cervical dilations of 5-7 cm and 8-9 cm. The control group received routine care. Mind-body index was assessed using the HeartMath device in both groups during labor. Pelvic floor-related distress was assessed using the Pelvic Floor Distress Inventory-20 at baseline and at 6 weeks postpartum.

Conditions

Labor Delivery; Relaxation; Pregnancy; Focus Health Pregancy Women; Breath Exercise; Imagery, Psychotherapy; Pelvic Floor Disorder; Pelvic Floor Muscle Activation

Keywords

Mental Toughness; Labor; Pelvic Floor

Outcome Measures

Primary Outcomes (1)

• Pelvic Floor Distress Inventory- 20

  Assesses the presence and severity of pelvic floor distress symptoms, including urinary, colorectal-anal, and pelvic organ prolapse-related symptoms, using the Pelvic Floor Distress Inventory-20 (PFDI-20).

  At baseline (third trimester of pregnancy) and at 6 weeks postpartum.

Secondary Outcomes (1)

• Mind-Body Index during Labor

  At 5-7 cm and 8-9 cm cervical dilation during active labor.

Study Arms (2)

Mental Toughness Intervenıons

EXPERIMENTAL

The group that will apply the mental resilience interventions taught during the last trimester of pregnancy (breathing exercises, relaxation techniques, focusing/concentration practices, and imagery) during the childbirth process."

Behavioral: Mental Toughness

Control Group

NO INTERVENTION

Routine care will be given

Interventions

Mental Toughness BEHAVIORAL

breathing exercises, relaxation techniques, focusing/concentration practices, and imagery

Mental Toughness Intervenıons

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women who are pregnant and aged 18 years or older are eligible for participation in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being primiparous
• Being in the third trimester of pregnancy
• Having no communication barriers
• Being a pregnant woman with an expectation of vaginal delivery

You may not qualify if:

• Being multiparous
• Having a diagnosis of high-risk pregnancy
• Having a diagnosed pelvic floor dysfunction (Urinary Incontinence, Fecal Incontinence, or Pelvic Organ Prolapse)
• Being under 18 years of age
• Having a planned cesarean delivery
• Study Discontinuation Criteria:
• Voluntary withdrawal from the study by the participant
• Emergency cesarean delivery decision
• Impairment of mental functions during the intrapartum or postpartum period

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases

Study Officials

• Hüsniye Dinç Kaya, PhD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Population and Sample of the Study: In the study, the sample size was calculated prior to data collection using the G\*Power 3.1.9.2 program at a 95% confidence level. Since no study could be found in the literature that could be used as a reference for the research objective, an effect size of 0.80-the lower limit of the high effect size range-was used to calculate the sample size for the difference between two groups. Accordingly, with an alpha value of 0.05 and a theoretical power of 0.80, the minimum sample size was calculated as 62 (Experimental Group = 31, Control Group = 31). \*\*Inclusion Criteria of the Study:\*\* * Being primiparous * Being in the 3rd trimester of pregnancy * Having no communication barriers * Pregnant women expecting a vaginal birth

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: August 18, 2026
• Study Start: January 15, 2026
• Primary Completion: June 15, 2026
• Study Completion: June 15, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Locations

TU (1)